Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
NCT ID: NCT01118689
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2010-11-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MLN0128
MLN0128
MLN0128 administered orally once daily for 28 days
Interventions
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MLN0128
MLN0128 administered orally once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
* Life expectancy of ≥3 months;
* Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
* For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
* Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
* Ability to swallow oral medications;
* Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;
Exclusion Criteria
* Known impaired cardiac function or clinically significant cardiac disease
* HIV infection;
* Failed to recover from the reversible effects of prior anticancer therapies:
* Pregnancy (positive serum or urine pregnancy test) or breast feeding;
* Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;
18 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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San Francisco, California, United States
Denver, Colorado, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
Nashville, Tennessee, United States
Countries
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Other Identifiers
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INK-128-002
Identifier Type: -
Identifier Source: org_study_id